Fortified micronutrient salt formulations

Abstract

Salt formulations, which are resistant to moisture and cooking conditions, are described herein. The formulations provide particles of micronutrients and vitamins encapsulated within heat resistant pH-sensitive water-insoluble polymers, which are packaged within a salt shell. The pH-sensitive, water-insoluble, thermally stable materials stabilize the micronutrients, particularly at high temperatures, such as during food preparation and cooking, and release the micronutrients at the desired locations such as the stomach, small intestine, etc. Preferred pH-sensitive polymers release at a low pH, less than the pH present in the stomach. The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt, eliminating the need for vitamin pills. This is particularly important in populations suffering from severe malnutrition.

We claim: 
     
       1. A salt formulation comprising:
 particles comprising one or more therapeutic agents, prophylactic agents, nutraceutical agents, diagnostic agents, or combinations thereof, 
 a matrix formed of inert excipient having the particles dispersed therein, 
 a pH-sensitive polymer coating on the outer surface of, or surrounding, the matrix, 
 wherein the composition, thickness and concentration of the pH sensitive polymer coating is effective to resist permeation of water into the matrix and prevent oxidation of the agents for one hour at 100° C., and provides release of the particles upon exposure to a pH and temperature in the gastrointestinal tract but not at a higher pH, 
 wherein the formulation is stable up to one hour at 100° C., and 
 a coating of one or more salts on the pH-sensitive polymer coating, 
 wherein the coating comprises between about 10 and 80% by weight of one or more salts selected from the group consisting of sodium or potassium chloride, magnesium chloride, potassium iodide, phosphates, and combinations thereof. 
 
     
     
       2. The formulation of  claim 1 , wherein the particles comprise vitamins, trace minerals, micronutrients, or combinations thereof. 
     
     
       3. The formulation of  claim 1 , wherein the matrix is partially or wholly formed of materials selected from the group consisting of salts, sugars, carbohydrates, oils, fats, waxes, proteins, and combinations thereof. 
     
     
       4. The formulation of  claim 1 , wherein the matrix is partially or wholly formed of a hydrogel. 
     
     
       5. The formulation of  claim 4 , wherein the hydrogel is formed of one or more polymers selected from the group consisting of hyaluronic acid, cyclodextrin, collagen, alginate, chitin, polyethylene glycol and copolymers thereof, ethylene glycol dimethacrylate, hydroxyethyl methacrylate, poly(butylene oxide), polycaprolactone, poly(ethylene oxide) and copolymers thereof, poly(ethylene imine), poly(ethyl methacrylate), propylene fumarate, poly(hydroxy butyrate), poly(hydroxyethyl methacrylate), poly(hydroxypropyl methacrylamide), poly(lactic acid), poly(lactic-co-glycolic acid), poly(N-vinyl pyrrolidone), poly(propylene oxide), poly(vinyl alcohol), poly(vinyl acetate), and poly(vinyl amine). 
     
     
       6. The formulation of  claim 1 , wherein the polymer coating comprises one or more pH-sensitive polymers that dissolve at a pH between about 1 and 5. 
     
     
       7. The formulation of  claim 1 , wherein the polymer coating comprises one or more pH-sensitive polymers that dissolve at a pH between about 5 and 8. 
     
     
       8. The formulation of  claim 1 , comprising pH-sensitive polymer selected from the group consisting of cationic polymers, polymers that become cationic under physiological conditions, and combinations thereof. 
     
     
       9. The formulation of  claim 1 , comprising pH-sensitive polymer selected from the group consisting of polymethacrylates containing functional groups that form salts at a pH greater than 5.0, naturally occurring cellulosic polymers, polysaccharides, polyvinyl acetate phthalate, shellac, fatty acids, waxes, plastics, plant fibers, and combinations thereof. 
     
     
       10. The formulation of  claim 2 , wherein the vitamins, trace minerals, and micronutrients are selected from the group consisting of iron, zinc, manganese, copper, iodine, selenium, molybdenum, chromium, vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9 (folic acid), vitamin B12, vitamin C, vitamin D3, vitamin E, vitamin K, pantothenic acid, biotin, and combinations thereof. 
     
     
       11. The formulation of  claim 1  further comprising anti-parasitic agents. 
     
     
       12. The formulation of  claim 11 , wherein the anti-parasitic agents are selected from the group consisting of antinematodes, anticestodes, antitrematodes, antiamoebics, antiprotozoals, and combinations thereof. 
     
     
       13. The formulation of  claim 12 , wherein the antinematodes are selected from the group consisting of mebendazole, pyrantel pamoate, thiabendazole, diethylcarbamazine, ivermectin, and combinations thereof. 
     
     
       14. The formulation of  claim 12 , wherein the anticestodes are selected from the group consisting of niclosamine, praziquantel, albendazole, and combinations thereof. 
     
     
       15. The formulation of  claim 1 , wherein the pH sensitive polymer is a copolymer formed of butyl methacrylate, dimethylaminoethyl methacrylate, and methyl methacrylate. 
     
     
       16. A method of providing salt, trace minerals, vitamins, micronutrients, or combinations thereof, the method comprising providing an effective amount of the formulation of  claim 1  to an individual in need thereof. 
     
     
       17. The method of  claim 16 , wherein the formulation is provided for cooking. 
     
     
       18. The method of  claim 16 , wherein the formulation is provided in bulk form to agricultural animals.